Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex

NCT02493244 | Completed

• 1 other identifier: 20714
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Tears play a vital role in vision. A thin layer of tears is always present to cover the surface of the eye for optimal comfort and vision. There are several layers to the tear film, and the outer most layer is comprised of lipids. This lipid layer prevents evaporation of the tears and may be disrupted in people suffering from symptoms of dry eye. Cleaning eyelids with Cliradex wipes have shown to be effective in reducing dry eye symptoms in some patients, and the purpose of this study is to evaluate the tear film lipid layer thickness before and after one months treatment with Cliradex Wipes.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Lipid layer thickness

  Lipid layer thickness measured in nm.

  Baseline

• Lipid layer thickness

  Lipid layer thickness measured in nm.

  1 month after baseline visit.

Secondary Outcomes (9)

• Non-invasive tear breakup time (NITBUT)

  Baseline

• Non-invasive tear breakup time (NITBUT)

  1 month after baseline visit.

• Dry Eye Questionnaire (SPEED score)

  Baseline

• Dry Eye Questionnaire (SPEED score)

  15 days after baseline visit.

• Dry Eye Questionnaire (SPEED score)

  1 month after baseline visit.

Study Arms (2)

Treatment

EXPERIMENTAL

Participants clean their eyelids with Cliradex wipes before going to bed at night.

Other: Cliradex

Control

NO INTERVENTION

No treatment

Interventions

Cliradex OTHER

Cliradex is simply water and 4-Terpineol, a natural organic compound found Melaleuca alternifolia. The other ingredients in Cliradex are in less than 1% of the formulation and are Glycerin, Polysorbate 20, Polysorbate 80, Carbomer, Triethanolamine.

Treatment

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 17 years of age and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Have not worn contact lenses in the past month;
• Has symptomatic dry eye with SPEED questionnaire score ≥6;
• Corneal staining grade ≥2 on the Oxford scale.

You may not qualify if:

• Has any known active ocular disease and/or infection;
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
• Have used rewetting drops for a period of 2 days prior to screening visit;
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
• Is pregnant, lactating or planning a pregnancy at the time of enrolment by verbal confirmation at the screening visit;
• Is aphakic;
• Has undergone refractive error surgery;
• Has taken part in another (pharmaceutical) research study within the last 30 days.

Sponsors & Collaborators

• University of Waterloo: lead
• Canadian Optometric Education Trust Fund (COETF): collaborator

Study Sites (1)

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Lyndon Jones, PhD

  CCLR, University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: July 9, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

CA (1)